Abstract | BACKGROUND: METHODS AND RESULTS: The IMPROVE-IT trial randomly assigned 18 144 patients stabilized after acute coronary syndrome to simvastatin or ezetimibe/ simvastatin. LDL-C and hs-CRP were measured at baseline and 1 month after randomization. Outcomes were assessed in those achieving one or both of the prespecified targets of LDL-C<70 mg/dL and hs-CRP<2 mg/L versus achieving neither target, adjusting for differences in baseline characteristics. An exploratory analysis examined targets of LDL-C<50 mg/dL and hs-CRP<1 mg/L. Patients meeting both targets at baseline, with no 1-month values, or with end points before 1 month were excluded. Of 15 179 patients, 39% achieved the dual LDL-C (<70 mg/dL) and hs-CRP (<2 mg/L) targets at 1 month, 14% met neither target, 14% met only the hs-CRP target, and 33% met only the LDL-C target. Those achieving dual targets had lower primary end point rates than those meeting neither target (cardiovascular death, major coronary event, or stroke; 38.9% versus 28.0%; adjusted hazard ratio, 0.73; 0.66-0.81; P<0.001). More patients treated with ezetimibe/ simvastatin met dual targets than those treated with simvastatin alone (50% versus 29%, P<0.001). The association of dual-target attainment with improved outcomes was similar irrespective of treatment assignment (P-interaction=0.65). Similar findings were observed using the exploratory targets. CONCLUSIONS: Significantly more patients treated with ezetimibe/ simvastatin met prespecified and exploratory dual LDL-C and hs-CRP targets than patients treated with simvastatin alone. Reaching both LDL-C and hs-CRP targets was associated with improved outcomes after multivariable adjustment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov; Unique identifier: NCT00202878.
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Authors | Erin A Bohula, Robert P Giugliano, Christopher P Cannon, Jing Zhou, Sabina A Murphy, Jennifer A White, Andrew M Tershakovec, Michael A Blazing, Eugene Braunwald |
Journal | Circulation
(Circulation)
Vol. 132
Issue 13
Pg. 1224-33
(Sep 29 2015)
ISSN: 1524-4539 [Electronic] United States |
PMID | 26330412
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Heart Association, Inc. |
Chemical References |
- Anticholesteremic Agents
- Biomarkers
- Cholesterol, LDL
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- C-Reactive Protein
- Simvastatin
- Creatinine
- Ezetimibe
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Topics |
- Acute Coronary Syndrome
(blood, drug therapy)
- Aged
- Anticholesteremic Agents
(administration & dosage, therapeutic use)
- Biomarkers
- C-Reactive Protein
(analysis)
- Cardiovascular Diseases
(mortality)
- Cerebral Revascularization
- Cholesterol, LDL
(blood)
- Comorbidity
- Creatinine
(blood)
- Double-Blind Method
- Drug Monitoring
- Drug Therapy, Combination
- Electrocardiography
- Ezetimibe
(administration & dosage, therapeutic use)
- Female
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Myocardial Infarction
(blood, drug therapy)
- Myocardial Revascularization
- Simvastatin
(administration & dosage, therapeutic use)
- Treatment Outcome
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